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November 20, 2009 Approval Letter - cobas TaqScreen MPX Test

Our STN:   BL 125255/3                                      

Roche Molecular Systems, Inc.
Attention:  Carol A. Pachl, Ph.D.
4300 Hacienda Drive
Pleasanton, CA  94566-2722

Dear Dr. Pachl:

We have approved your request to supplement your biologics license application for Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA, to include the additional claim of testing samples from source plasma donors in pools comprised of up to 96 individual donations.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567, as appropriate.  Please provide a PDF electronic copy as well as 3 original paper copies for circulars and other labels. 

Two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.  Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

All promotional claims must be consistent with and not contrary to approved labeling.  You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

 

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and
Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research